Improved Clinical Success with P-15 Peptide Enhanced Bone Graft as Compared to Autograft in TLIF: 2-Year Follow-up of a Multicenter, Prospective, Randomized Controlled Trial

Introduction: ABM/P-15 Matrix, an FDA breakthrough device, is a composite bone graft incorporating the P-15 peptide. This analysis presents the clinical success and safety outcomes from the multicenter FDA IDE RCT of ABM/P-15 Matrix versus local autograft in TLIF for the treatment of degenerative disc disease.

Methods: Patients, aged 22-80 years, were 1:1 randomized to either ABM/P-15 Matrix or local autograft control during single-level TLIF. The primary study outcome was a Composite Clinical Success (CCS) measure at 24-months, defined as having met all the following five criteria: no index level secondary surgical intervention; achievement of fusion; ≥15-point improvement in ODI from baseline; no new or worsening, persistent neurological deficit relative to baseline; and no serious device-related adverse events (AEs).

Results: A total of 290 patients from 33 sites were enrolled; 141 received ABM/P-15 Matrix, and 149 received autograft. 119 patients in the ABM/P-15 Matrix group and 128 in the autograft group were available for the 24-month follow-up. ABM/P-15 Matrix was both non-inferior (p < 0.0001) and superior (p=0.002) to autograft with respect to the CCS, with 55.5% of the ABM/P-15 Matrix group achieving clinical success compared with 37.5% of the autograft group. Fusion was statistically higher at 24-months (p < 0.0001) for the ABM/P-15 Matrix group than the autograft group (84.3% and 58.5%, respectively). The autograft group had significantly more patients with no index level secondary surgical interventions (95% CI -11.9%, -1.1%). There were no significant differences between groups with respect to ODI improvement, neurological deficits, serious device-related AEs or overall device-related AEs.

Conclusion : In this FDA IDE RCT, ABM/P-15 Matrix was statistically superior to local autograft in overall clinical success and fusion 2-years after instrumented TLIF. No significant differences in the incidence of AEs were observed, indicating ABM/P-15 is as safe as local autograft.